It is now established that islet replacement therapy is a viable approach for treatment of patients with various disorders. These include cancer patients undergoing upper abdominal exenteration (Tzakis, et al., Lancet, 336: 402-405 (1990)); pancreatitis (Clayton, et al., Transplantation, 76: 92-98 (2003); Farney, et al., Surgery, 110: 427-437 (1991); Fontes, et al., Transplant Proc, 24: 2809 (1992); Obenholzer, et al., Transplantation, 69: 1115-1123 (2000); Robertson, et al., Diabetes, 50: 47-50 (2001)), and insulin-dependent patients, where islet transplantation is a therapeutic option (Goss, et al., Transplantation, 74: 1761-1766 (2002); Ricordi, et al., Transplantation, 75: 1524-1527 (2003); Ryan, et al., Diabetes, 50: 710-719 (2001); Shapiro, et al., N. Engl. J. Med, 343: 230-238 (2000)).
Due to the usefulness of islets in therapy, as is indicated, supra, there is, of course interest in developing ways to isolate them. While there are many reports on isolation of islets using the automated method (Brandhorst, et al., Exp. Clin. Endocrinol Diabetes, 103 Suppl. 2: 3-14 (1995); Cui, et al., Cell Transplant, 6: 48-54 (2001); Marchetti, et al., Transplantation, 52: 209-213 (1991); Miyamoto, et al., Cell Transplant, 7: 397-402 (1998); Nielsen, et al., Comp. Med., 52: 127-135 (2002); Swanson, et al., Hum. Immunnol, 62: 73 9-749 (2001); Toomey, et al., Brit. J. Surg., 80: 240-243 (1993); Toso, et al., Cell Transplant, 9: 297-305 (2000); Wennberg, et al., Transpalnt. Proc., 33: 2537 (2001)), isolation of islets remains notoriously difficult. For example, Bosta, et al., J. Investig Med, 43: 555-566 (1995); Krickhahn, et al., Cell Transplant, 11: 827-838 (2002); Krickhahn, et al., Ann Transplant, 6: 48-54 (2001), O'Neil, et al., Cell Transplant, 10: 235-246 (2001), and White, et al., Horm. Metab. Res, 31: 579-524 (1999), all discuss problems with respect to this.
The invention which is set forth in the disclosure which follows is directed to a method for maximizing the probability of successful islet yield. It has been determined that via the use of the scoring system set forth herein, one can maximize the opportunity of securing a good yield of islets from any given pancreatic islet isolation.
How this is accomplished will be seen in the disclosure which follows.